If the Phase 2A tinnitus results are promising, where restoring IHC/OHC treats it as a symptom, I would expect a long-term shift in research. In any area of tinnitus research. The understanding of tinnitus in the case of SNHL/NIHL will be well known. As a result, research/commercial dollars may shift to other causes for treatment.
I still believe that to fix pain and loudness hyperacusis you need to fix the underlying issues in the ear such as OHCs, IHCs and synapses which FX-322, OTO-413 and Hough pill should do.
I think the thing about noxacusis (and just hyperacusis generally I guess) is that it is such a heterogeneous condition where the prognosis is really uncertain e.g. why do some cases resolve substantially whereas there are cases where it clearly becomes a chronic, intractable condition and seems to take on a life of its own.
I know it's speculation, but do you think there's a chance FX-322 may help loudness hyperacusis? I have severe reactive tinnitus, which I am starting to think is more akin to hyperacusis than it is to proper tinnitus. It's odd because my baseline is moderate, but every consistent external noise has a debilitating and intrusive reactive overlay attached to it that I can't mask.
I'm wholly with you on this topic. The chart that showed sources of tinnitus tends to be fairly accurate. Also, there is other evidence of reducing tinnitus like hearing aids and implants. It is quite likely we will see similar (hopefully better) results post the treatment. Pretty positive times ahead.
I don't think there is any reason to think this won't work as long as you have target cells (cells that the drug exerts its effects on I mean) left (LGR+support cells), so this should have at least some benefit up to profound ( > 90dB) loss imo.
Interesting. "Gaining additional insights on populations that FX-322 may treat"
Good timing - that day is today!When will the Frequency Therapeutics interview be released for Patreons of the Tinnitus Talk Podcast?
I'm incredibly grateful for this website, you guys are really on it!
Hopefully. If they have interim results that showed more effectiveness with the consistent redosing, then they might want to look into it more.
I have a similar thing where the sounds that irritate my ear (pain hyperacusis symptoms) most i.e. artificial audio in turn produce a reactive tinnitus which seems to be the same frequency as the external noise. This results in a very piercing and abrasive reactive tinnitus that I can almost physically 'feel' as well as hear.
Listen to the interviewI think that in an indirect way they are trying to 'increase the concentration' by repeating that safe phase 1 dose four times. To increase the concentration in a single dose would maybe entail a new round of trials. They won't risk the unknown by using a different concentration on something as delicate as the cochlea. Like @FGG mentioned earlier, it makes sense for them to try and reach all frequencies.
With regards to expanding the patient population (for example with regards to severity of hearing loss), I don't see why a Phase 2b trial couldn't include those patients. I do think they will expand to severe/profound. They are already testing mild hearing loss patients in Phase 2a, so the only way of expanding would be with patients beyond moderate-severe hearing loss.
According to the Clinical Trial site, yes... the inclusion criteria states "Pure Tone Audiometry (PTA) within 26-70 dB in the ear to be injected." 26 dB PTA appears to be in the middle of the Mild range. However, they have stated that they're screening for patients that match those that had "the most room for improvement" similar to the Phase 1/2. So, it's likely they have a secondary screening process that accepts participants in the Moderately-Moderately Severe PTA range. More room for improvement, more significant results. This also aligns with the primary outcomes of the Phase 2A, which is what the FDA will use as a final measurement for approving the drug.
I mean, I doubt they'll take that model. Annual ENT and Audiologist would be a bit extreme, but it would give them a better understanding of what causes tinnitus, and something to do about hearing loss, so I could see it becoming a greater part of doctor visits. And, if it resolves acute tinnitus in the upper frequencies, as I expect it would, then I can't imagine people would treat tinnitus as they do now, where there's nothing that can be done, so eh. I believe it would increase understanding of it, though I worry it would also lead to other possible solutions being brought to a close. If you find a way to resolve acute tinnitus, you have effectively resolved the issue for everyone that comes after, making a solution to the chronic case less profitable. It's essentially the CGP Grey video where you're asked which side of the line of curing death do you want to be on.
So, If I am understanding this correctly. You are suggesting institutionalizing hearing loss education by coordinating government, institutional, and private entities? I don't see it happening; too ideological. People can't even get it into their heads to wear a facemask to prevent the spread of COVID-19 in the US where daily data is presented to them via the media, government, and private entities coordinating.
I think attempting multiple doses is much easier to try to do for now than trying to restart using a bigger dose.
It treats frequencies upwards from 8000 Hz according to the trial information thus far. You need to remember that they have tested one dose only so far so they do not know the full facts around multiple doses etc. Supposedly in vitro this worked within all areas and thus it is a matter of getting it delivered to all parts of the ear.
Once they release FX-322 out to the public with their current delivery method it shouldn't take too long to release the new delivery method if they have created one. I heard it takes about a year to test out a new delivery method once it's out.
Posted the response in the awareness thread, as that's more what this discussion is.
Good point about gaining more profit with the use of FX-322 ads. Maybe this will allow people to treat hearing loss seriously but they also need to talk about hyperacusis and tinnitus.
It was was also fairly neutral too. It was especially comforting to know that there is positive progress and positive plans in place to get this right and make it work.
Member
Founder
